_This piece originally appeared in the February 2018 issue of the Allegheny County Medical Society Bulletin._
_Richard L. Holzworth writes:_
In April 2016, Gov. Tom Wolf signed into law Pennsylvania’s compassionate medical cannabis legislation (Act 16), effectively legalizing medical marijuana in the Commonwealth. Since that time, the Pennsylvania Department of Health (DOH) has awarded 12 licenses to grow medical marijuana and 27 licenses to operate medical marijuana dispensaries. It is anticipated that the grow operations and dispensaries will be open for business in early 2018. Although the proponents of medical marijuana have enjoyed widespread support (as evidenced by the 29 states that have enacted a medical marijuana law, including six since 2016), those in the industry are left to trust that Pennsylvania physicians will register with the DOH and send patients to the dispensaries. In other words, now that the legal medical marijuana system is in place, the onus is on physicians to ensure that patients have access to treatment.
PATIENT AND PHYSICIAN REGISTRATION
It is important for medical professionals to understand that they are not permitted to “prescribe” medical cannabis products. Rather, physicians who have met the registration requirements of Act 16 are permitted to issue “certifications” to patients who qualify for medical marijuana treatment.
In order for a patient to qualify for medical marijuana treatment, the patient must obtain a certification from a registered physician stating that the patient suffers from one of the 17 “serious medical conditions” identified in Act 16. These conditions include:
* Amyotrophic Lateral Sclerosis;
* Autism;
* Cancer;
* Crohn’s Disease;
* Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
* Epilepsy;
* Glaucoma;
* HIV/AIDS;
* Huntington’s Disease;
* Inflammatory Bowel Disease;
* Intractable Seizures;
* Multiple Sclerosis;
* Neuropathies;
* Parkinson’s Disease;
* Post-Traumatic Stress Disorder;
* Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective; and
* Sickle Cell Anemia.
Once a patient obtains a certification, then the patient must apply for a medical marijuana ID card through DOH. If the application is accepted, the patient (or a qualified, registered caregiver) may take the medical marijuana ID card to a state-licensed dispensary to obtain marijuana products.
In order for physicians to issue medical marijuana “certifications,” they must register with the DOH and complete a four-hour training course offered by DOH-approved providers. The DOH training course covers the following areas:
* Summary of Act 16;
* General information about medical marijuana under state and federal law;
* Scientific research on medical marijuana;
* Recommendations for medical marijuana, including pain management, risk management, palliative care, misuse of opioids and medical marijuana, and informed consent.
Physicians also are required to be licensed to practice medicine in Pennsylvania and be qualified, by training or experience, to treat at least one of the 17 serious medical conditions.
Once registered, the DOH will place the physician’s name, business address and medical credentials on the physician medical marijuana registry. The registry does not include contact information (telephone numbers or email addresses).
Importantly, registered physicians are not permitted to advertise that they are credentialed to certify patients for medical marijuana use. The DOH regulations have not provided much guidance in the way of what constitutes “advertising” or what is actually permitted, including whether physicians may list medical cannabis certification on their “menu” of services.
Copyright: megaflopp / 123RF Stock Photo
A CERTIFIED PHYSICIAN’S OBLIGATIONS
Prior to issuing a medical marijuana certification to a patient with a serious medical condition, registered physicians are required to consult with the patient and review the Prescription Drug Monitoring Program and the patient’s controlled substance history.
In certifying that a patient may use medical cannabis products, physicians are required to identify the recommendations, requirements and limitations as to the form of cannabis and the dosage. The certification also must state the length of time (not to exceed one year) for which the physician believes medical marijuana will be therapeutic or palliative. Physicians are permitted to recommend that a patient consult with a medical professional employed by a medical marijuana dispensary. For example, medical marijuana dispensaries must have a pharmacist on staff, and certifying physicians may defer to the pharmacist’s expertise.
Registered physicians are required to provide continuing care to their patients for the serious medical condition. During the ongoing care of patients, physicians are required to notify the DOH if:
* The patient no longer has the serious medical condition for which the medical marijuana certification was issued;
* Medical marijuana would no longer be therapeutic or palliative; or
* The patient has died.
OBSTACLES TO PHYSICIAN CERTIFICATION
On July 26, 2017, the DOH opened the physician registry, and Pennsylvania physicians were able to begin the registration process. As of Jan. 5, 2018, approximately 250 physicians have registered for the medical cannabis program, and an additional 400 physicians have started the process. While these numbers place Pennsylvania ahead of the curve compared to other states with similar registration processes, registration is still well below the 75 percent of Pennsylvania physicians who have indicated that they intend to register for the program. With more than 10,000 patients already registered for the medical marijuana program, some physicians are reporting a waiting list of up to 1,000 patients seeking certification.
There are several factors contributing to the shortfall of registered physicians. These factors include:
* Medical marijuana is still illegal under federal law;
* Cannabis products are not an FDA approved treatment;
* The cost of cannabis products is not covered by most medical insurances;
* The Pennsylvania Medical Society in 2015 voted to oppose the Pennsylvania Medical Marijuana Act; and
* Attorney General Jeff Sessions’ opposition to legalized marijuana.
Certainly, the political and medical/ scientific concerns are important; however, they are outside the scope of this article. With respect to the legal concerns, there is justifiable consternation in the health care community regarding potential criminal prosecution of physicians certifying the use of medical cannabis products, especially considering the recent actions of the Department of Justice and Attorney General Jeff Sessions.
The Obama Administration’s policy toward marijuana was set forth in a series of documents drafted by U.S. Department of Justice Deputy Attorney General James Cole (commonly referred to as the Cole Memorandum). This policy directed federal prosecutors to use investigative and prosecutorial resources to address the most significant threats in the most effective, consistent and rational way, which does not include prosecuting physicians, patients and others who are engaged in the medical marijuana business within a state that permits such activities. The implication of this policy was that federal prosecutors should refrain from investigating and prosecuting cannabis operations that are legal under applicable state law.
Furthermore, the Consolidated Appropriations Act of 2016, Section 542 (specifically, the Rohrabacher-Blumenauer Amendment) precludes the Department of Justice from spending funds on the prosecution of individuals who are engaged in conduct permitted by state medical marijuana laws (such as Act 16) and who fully comply with state laws. The Rohrabacher-Blumenauer Amendment was passed in December 2014 as part of an omnibus spending bill, and must be renewed each fiscal year in order to remain in effect. Attorney General Jeff Sessions has called on Congress not to renew the Rohrabacher-Blumenauer Amendment, but it has been renewed in the most recent stopgap spending bill.
Federal district courts have provided those in the medical marijuana industry with additional comfort that they will not be prosecuted for operating within the parameters of state medical marijuana programs. In 2015, the Ninth Circuit Court of Appeals ruled that the Department of Justice is prohibited from prosecuting any individual engaged in the use, distribution, possession, or cultivation of medical marijuana, provided that those activities are conducted in strict compliance with the state’s applicable medical marijuana law. However, failure to strictly comply with state law could result in federal prosecution.
On January 4, 2018, Attorney General Jeff Sessions rescinded the guidance provided in the Cole Memorandum. While initial reactions to Mr. Sessions’ announcement have ranged from panic to outrage to defiance, it is still unclear what new policies (if any) will arise from this decision and whether this decision will be supported by other branches and agencies of the federal government. Mr. Sessions’ decision to reverse course from the Obama Administration does not necessarily change the landscape of Pennsylvania’s medical marijuana industry, because marijuana has been and remains illegal under federal law.
For those in the medical marijuana industry in Pennsylvania, including registered physicians and physicians considering registration, it is important to recognize that Mr. Sessions’ actions did not create any new rights, either substantive or procedural, that are enforceable in a civil or criminal legal action. Mr. Sessions simply stated that each United States Attorney’s office has the discretion to prioritize enforcement of federal laws. In other words, local prosecutors may continue to follow Obama-era enforcement guidelines. Furthermore, as long as the Rohrabacher-Blumenauer Amendment remains in effect, the Justice Department and each local U.S. Attorney’s Office are not permitted to spend funds to investigate or prosecute state-licensed medical cannabis business.
CONCLUSION
There certainly is trepidation among physicians with regard to compliance with a new regulatory scheme, federal law and shifting federal policies and enforcement priorities. But compliance with state law is possible, and the various legal issues can be navigated with the help of experienced counsel.
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_RICHARD L. HOLZWORTH is an associate in the firm's Litigation Department, resident in its Pittsburgh office._

Earlier this month, Attorney General Jeff Sessions issued a Memorandum rescinding the Obama Administration's "hands off" policy with respect to the prosecution of licensed cannabis distribution in states where medical or recreational marijuana are legalized. Our sister blog, "In the Weeds" has covered the issuance of this new Memorandum extensively, including how it may affect state medical marijuana programs around the country. Copyright: megaflopp / 123RF Stock Photo
So far, U.S. Attorneys in many of the states that have legalized medical marijuana (including Pennsylvania) have made public statements to the effect that they are not interested in prosecuting violations of federal law with respect to cannabis, especially if the activity involved is in compliance with state law.
* For more information on the Sessions Memorandum, please see this post.
* For more information on the responses to the Memorandum from U.S. Attorneys (including the U.S. Attorney for Pennsylvania's Middle District), please see this post.
* For Pennsylvania physicians, it appears that the medical marijuana program continues to be on track for implementation on April 1, 2018. Pennsylvania Gov. Wolf issued a statement in response to the Sessions Memorandum confirming that he would seek legal action against the federal government to the extent that the federal government interferes with Pennsylvania's medical marijuana program. [See Governor Wolf's statement].
Stay tuned to Fox Rothschild's Physician Law Blog for updates on how the Sessions Memorandum will affect state medical marijuana programs.

Fox Rothschild's HIPAA & Heath Information Technology Blog recently published two posts directly relevant to physicians and medical practices. The first post, 5 Common HIPAA Mistakes to Avoid in 2018, addresses some typical misconceptions regarding disclosure of protected health information (PHI) and offers some ideas regarding how to avoid them.
The second post, New HIPAA Guidance on Disclosure of PHI related to Opioid Abuse and Mental Health, touches on the most recent HIPAA guidance released by the U.S. Department of Health and Human Services, Office of Civil Rights (OCR) regarding when and to whom PHI of patients suffering from addiction and mental illness may be shared. Among other things, the guidance addresses disclosure of PHI to family members or friends of patients in situations where the patient is incapacitated or there is a serious or imminent threat to the patient's health. The guidance also addresses HIPAA's rules on sharing PHI regarding a patient's substance abuse or mental health with other treating physicians.
The OCR has published webpages on its website to make this guidance easily accessible and understandable to health care professionals and patients.
As always, if you have a specific question regarding your practice, please consult a knowledgeable attorney.

CMS recently issued an Advisory Opinion suggesting that physicians who refer diagnostic tests reimbursable under Medicare to a laboratory may, under certain circumstances, receive electronic pop-up notifications in the laboratory’s web-based portal alerting the physicians to various potential issues related to the test results. In the Advisory Opinion, CMS considered certain alerts which a laboratory proposed to provide to its referring physicians without charge via the laboratory’s web-based portal. The entire Advisory Opinion can be read here.
In short, CMS concluded that the alerts proposed by the laboratory, which would be limited to issues relating to the test results, would not constitute illegal remuneration under the federal Stark law, as long as (1) the alerts are provided solely in connection with the ordering or communication of diagnostic test results from the laboratory, and (2) appropriate safeguards are in place to avoid overutilization or medically unnecessary testing.
Some of the key safeguards that CMS found persuasive included the following:
* Alerts recommending additional testing would be based on industry-standard, peer-reviewed guidelines;
* The alerts would not be “overly intrusive” and would not override the physician’s independent medical judgment;
* Where multiple additional tests would be recommended in an alert, there would be no “select all” button for the physician to click to order all of the tests together;
* The physician could turn off the alerts for a particular disease condition; and
* The physician could obtain the information provided in the alerts free of charge from other sources.
An advisory opinion from CMS is a rare occurrence, in comparison to advisory opinions issued by the Office of Inspector General regarding the federal Anti-Kickback Statute, which occur a number of times each year. This is the first and only advisory opinion issued by CMS in 2017. To that end, CMS likely considers this Opinion to be useful guidance to physicians and providers regarding their use of online web portals to order diagnostic tests.
If you or your practice has any questions regarding alerts or other benefits you may receive via a laboratory’s online web portal, please consult experienced legal counsel.

[For more information on CMS’s new Quality Payment Program and what physicians need to report in 2017, please see our prior blog posts here and here.]
CMS recently issued guidance (accessible here) on the three-part “Prevention of Information Blocking” attestation which physicians and other eligible clinicians will need to submit to CMS in order to qualify for points under the “Advancing Care Information” category of the Merit-based Incentive Payment System (MIPS).
Although making this attestation and reporting to CMS regarding use of certified EHR technology (CEHRT) is not required to avoid a penalty under the MIPS for 2017, many physicians and group practices wish to report as much as they reasonably can to seek a high score under the MIPS and a positive payment adjustment to their Medicare reimbursements in 2019.
The three-part attestation centers on the representation that the physician/group practice will not knowingly and willfully limit or restrict the compatibility or interoperability of its CEHRT. CMS’s guidance makes clear that physicians and group practices making the attestation must use good faith and reasonable efforts to enable the exchange of electronic health records between appropriate parties.
According to CMS, examples of situations where access to CEHRT could be reasonably restricted include:
* System Maintenance -- Disabling CEHRT for as long as reasonably necessary to complete system maintenance, provided that requests for access to EHR information during such time period are responded to when practical;
* Security Concerns -- Blocking access to CEHRT when reasonably necessary to ensure the security of EHR information, provided that the blocking was narrowly tailored to the bona fide threat; and
* Patient's Health and Well-Being -- Restricting access to certain information (such as a patient’s sensitive test results), if the clinician reasonably believes that the restriction is necessary to protect the patient’s health or well-being. In the case of sensitive test results, CMS suggests that restricting access to the results could be reasonable until the physician or clinician who ordered the test has reviewed and appropriately communicated the results to the patient.
CMS expects that physicians and group practices making the attestation will ensure that their organizational policies and workflows will not restrict functionality of the CEHRT in any way, and that they will work with their CEHRT vendors to ensure that the CEHRT is fully functional.
If you or your practice will be reporting EHR data to CMS under the MIPS for 2017, a full review of CMS’s guidance on the attestation is recommended (see the five-page guidance here). All physicians and practices reporting EHR data under the MIPS have until March 31, 2018 to report the data and make the attestation.

Gov. Christie’s Administration recently proposed a regulation to curtail the prescription of unnecessary opioid painkillers. Christie, who serves as the Chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis, expressed concern that treatment decisions of all prescribers (including physicians, dentists and advanced practice nurses) are being improperly influenced by pharmaceutical companies. According to Christie’s press release, four out of every five new heroin users began by misusing prescription painkillers, and, in 2016, $69 million was paid to physicians in New Jersey by drug companies and device manufacturers, two-thirds of which went to just 300 physicians.
The New Jersey regulation would take big steps toward restricting what prescribers may receive from pharmaceutical companies, including limiting the value and frequency of meals that may be provided in educational settings, and prohibiting the giving of a variety of items to prescribers, except in limited circumstances (such as for educational materials, for presenting at continuing education events and for bona fide consulting arrangements). Annual payments for bona fide services would be limited to $10,000.
The proposed regulation will be published for comment in the New Jersey Register on October 2, 2017. Stay tuned to Fox Rothschild’s Physician Law Blog for updates.

As first reported on our sister blog, "In the Weeds" (post accessible here), on July 26, 2017, the Pennsylvania Department of Health opened its Medical Marijuana Practitioner Registry. Physicians licensed in the Commonwealth of Pennsylvania may now apply online to register to certify the use of medical marijuana for their patients. The online application may be completed here. Copyright: megaflopp / 123RF Stock Photo
The Practitioner Registry will be publicly searchable and will include each practitioner’s name, business address, and medical credentials. As noted in one of our prior blog posts on the subject (accessible here), it is still unclear whether practitioners may represent on their own practice websites that they are registered with the Pennsylvania Department of Health to certify the use of medical marijuana.
In order to complete the registration process, physicians will be required to complete a four-hour training program on the use of medical marijuana to treat serious medical conditions. As part of its Press Release on the opening of the Practitioner Registry, the Department of Health has announced that the following two continuing education providers have been approved to offer the training program to practitioners at this time: Answer Page Inc. and Extra Step Assurance LLC. Further information on the training courses can be found at the companies' websites.
For more information on Pennsylvania's Medical Marijuana Program and how it applies to practitioners, please see our prior blog post on the subject (link), as well as the state website for the Program (accessible at this link). According to the Press Release, Pennsylvania's Medical Marijuana Program is still on track to be fully implemented in 2018.

Under CMS's new Quality Payment Program, which will adjust Medicare Part B payments starting in 2019 based on data from this year, physicians and other eligible clinicians must qualify for one of two payment "tracks", either the Merit-Based Incentive System (MIPS) or the Advanced Alternative Payment Model (Advanced APM) track. A physician who qualifies under the MIPS in 2017 can earn up to a 4% payment adjustment to Medicare Part B payments in 2019. Physicians who qualify under the Advanced APM track can earn up to a 5% payment adjustment in 2019. For more information on the Quality Payment Program and the MIPS, please see our prior blog post on the topic here.
Since the Quality Payment Program went into effect on January 1, 2017, it has been unclear whether physicians participating in an Advanced APM in 2017 would be able to meet CMS' quality and reporting requirements and earn a 5% payment adjustment to their Medicare Part B claims in 2019.
CMS recently provided clarity on this issue by predicting that ALMOST 100% of physicians and other eligible clinicians participating in Advanced APMs in 2017 will qualify for a 5% payment adjustment to their Medicare Part B claims in 2019. CMS based this prediction on an analysis of Advanced APM claims data submitted from January through August 2016 (before the Quality Payment Program went into effect).
CMS also stated that physicians who participate in an Advanced APM need to meet only one of two criteria to earn the 5% payment adjustment in 2019: (1) receive 25% of the physician’s Medicare Part B payments through the Advanced APM; or (2) see 20% of the physician’s Medicare patients through the Advanced APM. [A list of Advanced APMs in which a physician may participate in 2017 can be found at the following link: CMS List of Advanced APMs]
Participating in an Advanced APM can have several benefits (including being exempt from reporting quality data under the MIPS payment track), but also involves taking on some risk. If you are considering participation in an Advanced APM, please contact an experienced attorney to discuss.
CMS is expected to issue formal determinations regarding the qualification of particular physicians for the Advanced APM track later this year. Stay tuned to Fox Rothschild's Physician Law Blog for updates.

On June 20, 2017, The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule which would exempt a greater number of small practices from complying with the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”).
CMS’s Administrator, Seema Verma has been quoted as saying that CMS has “heard the concerns that too many quality programs, technology requirements and measures get between the doctor and the patient. . . That’s why we’re taking a hard look at reducing burdens. ”
In order to accomplish this goal, CMS proposes to now exempt physician practices with less than $90,000 in Medicare revenue or physicians with fewer than 200 unique Medicare patients. The current rule only exempts physician practices that have less than $30,000 in Medicare revenue or fewer than 100 unique Medicare patients. This proposed rule could mean another 834,000 clinicians could be exempt from the quality reporting under MACRA.
While this seems like a large increase in the number of physicians that are exempt, a recent Modern Healthcare article notes that “65% of Medicare payments would still be reported under methods that adhere to MACRA even if this draft rule were finalized.”
If you are interested in commenting on the proposed rule you may do so through August 30, 2017. The proposed rule can be found at the following website: Proposed Rule.
If you would like more information about MACRA please see the Fox Rothschild Health Law Alert – Medicare Quality Payment Program from January 2017.

The Medicare Access and CHIP Reauthorization Act of 2015 requires Centers for Medicare and Medicaid Services (“CMS”) to remove Social Security Numbers (“SSNs”) from all Medicare cards. Physicians currently use a SSN-based Health Insurance Claim Number (“HICN”) for Medicare transactions like billing, eligibility status, and claim status. Starting April 1, 2018, CMS will begin mailing new cards with a randomly assigned Medicare Beneficiary Identifier (“MBI”) to replace the existing HICN. All Medicare cards will be replaced by April 1, 2019, affecting approximately 57.7 million beneficiaries.
The initiative is intended to better protect private health care and financial information; however, many physicians are unclear as to their responsibilities to ensure that billing privileges aren’t affected. Although CMS has designated the time period running from April 1, 2018 through December 31, 2019 as a transition period, during which physicians may use either the HICN or MBI in Medicare transactions, physician systems must be able to accept the new MBI format by April 1, 2018, which is the beginning of the transition period.
Earlier this month, CMS released a five-point bulletin on steps physicians can take to prepare for the change. CMS advises physicians to do the following:
* Go to CMS’ provider website and sign up for the weekly MLN Connects newsletter;
* Attend CMS’ quarterly calls to get more information;
* Verify all Medicare patients’ addresses. If the addresses on file are different than the Medicare addresses on electronic eligibility transactions, ask patients to contact Social Security and update their Medicare records;
* Work with CMS to help patients adjust to their new Medicare cards. When available later this fall, display helpful information about the new Medicare cards; and
* Test system changes and work with billing office staff to be sure the office is ready to use the new MBI format.